Is there a generic for Estradiol acetate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Estradiol acetate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Estradiol acetate?

FEMTRACE (NDA 021633, APIL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Estradiol acetate are approved?

Estradiol acetate is approved in the following dosage forms: insert, extended release, tablet.

FDA Orange Book · active-ingredient family

Estradiol acetate

Estradiol acetate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:FEMTRACE · NDA 021633

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · insert, extended release, tablet

Product	Applicant	Application	TE	Approved
FEMTRACERLD×3	APIL	NDA 021633	—	Aug 20, 2004
FEMRINGRLD×2	MILLICENT MFG PR	NDA 021367	—	Mar 20, 2003

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Estradiol acetate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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